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EC number: 474-870-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 May 2007 to 22 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 474-870-9
- EC Name:
- -
- Cas Number:
- 80156-97-4
- Molecular formula:
- Hill formula: C28H20ClN9Na4O16S5 CAS formula: C28H24ClN9O16S5.4Na
- IUPAC Name:
- tetrasodium 7-[(1E)-2-[2-(carbamoylamino)-4-{[4-chloro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}phenyl]diazen-1-yl]naphthalene-1,3,6-trisulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 176 Ester
Reactive Yellow 176 Sulfato
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain: CRL:(WI)BR Wistar rats
Source: CHARLES RIVER (EUROPE) LABORATORIES INC. TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rat as a rodent is one of the standard species of acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female; female rats were nulliparous and non-pregnant.
Age of animals: Young adult rats
Body weight range at the treatment: Male 241 - 248 g
Female 200 - 212 g
Animals arrived: 03 May 2007
Acclimatization time: 5 days
Animal health: Only healthy animals were used for the study. The veterinarian certified health status.
Number of animal room: 245/9
Housing: Individual caging
Cage type: Type II polypropylene/polycarbonate
Bedding: Laboratory bedding
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 8-12 air exchanges/hour by central air-condition system.
Food and Water Supply The animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from municipal supply from 500 ml bottle, ad libitum.
The diet and drinking water are routinely analysed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animal Identification: The individual identification was performed by numbers on the tail written with a permanent marker. The cages were marked by identity cards with information about study code, sex, dose group, cage number and individual animal number.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- moistened with 0.5 ml of distilled water.
- Details on dermal exposure:
- For the treatment the test item was applied in its original form moistened with 0.5 ml of distilled water.
The test item was not expected to be lethal at dermal 2000 mg/kg bw based on data provided by Sponsor. No test item related mortality occurred, thus full test was not conducted. A limit test was carried out involving a dose group of 2000 mg/kg bw with five animals/sex.
A single administration was performed by dermal route and was followed by a fourteen-day observation period.
The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a single dose in original form uniformly over the shaved skin throughout a 24- hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi occlusive plastic wrap for 24 hours.
At the end of the exposure period, residual test item was removed, using body temperature water. - Duration of exposure:
- 24 h
- Doses:
- Dose Group Number of animals
2000 mg/kg bw male 5
2000 mg/kg bw female 5 - No. of animals per sex per dose:
- Dose Group Number of animals
2000 mg/kg bw male 5
2000 mg/kg bw female 5 - Control animals:
- no
- Details on study design:
- Clinical Observations
Careful clinical observation was made at the following intervals: 1h, 5h after the treatment and once each day for 14 days thereafter.
Individual observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern as well. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight Measurement
The body weight of each animal was recorded on day 0 (shortly before the treatment), then on days 7 and 14 with precision of 1 g.
NECROPSY
At the end of the observation period gross pathology was conducted in every experimental animal. Animals were exsanguinated under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic, and abdominal cavities were opened and tissues, organs were observed. Gross pathological changes were recorded for each animal on the post mortem record sheets. - Statistics:
- Frequency of the clinical signs and necropsy findings by sex were presented in tabular form.
The mean body weight and standard deviation were calculated.
Results and discussion
- Preliminary study:
- The test item was not expected to be lethal at dermal 2000 mg/kg bw based on data provided by Sponsor. No test item related mortality occurred, thus full test was not conducted. A full test needs to be considered, only if compound related mortality occurs (TGs OECD 402, Dir. 92/69/EC B.3 and OPPTS 870.1200.).
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to Gelb Sulfato in CRL:(WI) BR rats.
- Clinical signs:
- other: No behavioural or dermal changes or general toxic symptoms were noted during the study. The skin became yellow - red coloured after the patch removal, which disappeared between days 3 and 10.
- Gross pathology:
- Test item related macroscopic alterations were not found at the gross pathology. Pinprick-sized haemorrhages (2/5 male, 2/5 female) were observed in the lungs, which were caused by exsanguination procedures. Hydrometra due to the sexual cycle occurred in female animals (3/5).
- Other findings:
- None.
Any other information on results incl. tables
CLINICAL OBSERVATIONS
SUMMARY OF CLINICAL OBSERVATIONS
Group |
Observations |
Frequency |
|
Male |
Female |
||
2000 mg/kg bw |
Yellow – red coloured normal skin |
5/5 |
5/5 |
Cessation of discolouration |
Between days 3 and 10 |
Between days 3 and 9 |
Comment: Frequency = number of animals with symptom / number of animals observed
INDIVIDUAL CLINICAL OBSERVATIONS
Group |
Animal Number |
Observations |
Day 0 |
Days |
F |
|||||||||||
1h |
5h |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11-14 |
||||
2000 mg/kg bw Male |
5586 |
Normal |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/16 |
Yellow-red coloured skin |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2/16 |
||
5587 |
Normal |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2/16 |
||
5588 |
Normal |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
7/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9/16 |
||
5589 |
Normal |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
12/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
4/16 |
||
5590 |
Normal |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
8/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
8/16 |
||
|
||||||||||||||||
Group |
Animal Number |
Observations |
Day 0 |
Days |
F |
|||||||||||
1h |
5h |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11-14 |
||||
2000 mg/kg bw Female |
5631 |
Normal |
+ |
+ |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
11/16 |
Yellow-red coloured skin |
- |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
5/16 |
||
5632 |
Normal |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2/16 |
||
5633 |
Normal |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2/16 |
||
5634 |
Normal |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
8/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
8/16 |
||
5635 |
Normal |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/16 |
|
Yellow-red coloured skin |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2/16 |
Skin = Treated skin surface. It was intact in each case.
Comment: F = Frequency of symptom = number of occurrence of symptom / total number of observations
+ = Observation present, - = Observation not present; h = hours;
NECROPSY FINDINGS
TEST ITEM: GELB SULFATO |
TEST SYSTEM: CRL: (WI) BR RAT |
STUDY CODE: 07/425-002P |
||||||
MODE OF ADMINISTRATION: DERMAL |
SEX: MALE |
DURATION OF STUDY: 14 DAYS |
||||||
DOSE: 2000 MG/KG BW |
NUMBER OF ANIMALS: 5/5 |
DATE OF NECROPSY: 22 MAY 2007 |
||||||
NECROPSY FINDINGS PER ORGANS |
ANIMAL NUMBERS: |
5586 |
5587 |
5588 |
5589 |
5590 |
NECROPSY FINDINGS |
|
Σ |
% |
|||||||
LUNGS |
Pinprick-sized haemorrhages |
- |
- |
- |
+ |
+ |
2 |
40 |
NO ORGANS WITH MACROSCOPIC FINDINGS |
+ |
+ |
+ |
- |
- |
3 |
60 |
|
|
||||||||
TEST ITEM: GELB SULFATO |
TEST SYSTEM: CRL: (WI) BR RAT |
STUDY CODE: 07/425-002P |
||||||
MODE OF ADMINISTRATION: DERMAL |
SEX: FEMALE |
DURATION OF STUDY: 14 DAYS |
||||||
DOSE: 2000 MG/KG BW |
NUMBER OF ANIMALS: 5/5 |
DATE OF NECROPSY: 22 MAY 2007 |
||||||
NECROPSY FINDINGS PER ORGANS |
ANIMAL NUMBERS |
5631 |
5632 |
5633 |
5634 |
5635 |
NECROPSY FINDINGS |
|
Σ |
% |
|||||||
LUNGS |
Pinprick-size haemorrhages |
- |
+ |
+ |
- |
- |
2 |
40 |
UTERUS |
Hydrometra |
- |
- |
1 |
1 |
2 |
3 |
60 |
NO ORGANS WITH MACROSCOPIC FINDINGS |
+ |
- |
- |
- |
- |
1 |
20 |
COMMENT: NO ALTERATION = -
ALTERATION PRESENT = +
NO DATA = /
GRADE OF ALTERATION 1 = SLIGHT / SMALL / FEW
2 = MODERATE / M.SIZE / M. NUMBER
3 = MARKED / MANY / LARGE
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under our experimental conditions, the acute dermal LD50 value of the test item Gelb Sulfato was greater than 2000 mg/kg bw in male and female CRL: (WI) BR Wistar rat.
Gelb Sulfato does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances. - Executive summary:
The acute dermal toxicity of test item Gelb Sulfato was assessed in rats to provide information on health hazards likely to arise from 24-hour exposure by the dermal route.
A limit test according to OECD 402 and B.3. 92/69/EEC was performed with Gelb Sulfato in CRL: (WI) BR rats. The study was performed in accordance with the Principles of Good Laboratory Practice (GLP) and reported with a GLP certificate.
Five male and five female animals were treated with Gelb Sulfato for a single 24-hour dermal exposure in its original form at a dose level of 2000 mg/kg bw.
Clinical examinations were made on the day of treatment 1 h and 5 h after the application of the test item, and once each day for 14 days thereafter. The body weights of animals were recorded on day 0 and weekly thereafter. A gross necropsy was performed in all animals at the end of observation period.
Results
Mortality:None of the animals died.
Dose
2000 mg/kg bw
Male treated
5
Mortality
0/5
Female treated
5
Mortality
0/5
Clinical observations:Gelb Sulfato caused yellow – red discolouration of the treated skin for 2 - 9 days after the patch removal.
There were no behavioural changes or general toxic signs. Behaviour and general state of animals were considered to be normal.
Body weight and body weight gain:The body weight development was not influenced by the single dermal treatment with the test item Gelb Sulfato.
Necropsy:Test item related specific macroscopic alterations were not found.
Conclusions
Under the conditions of the present study, single 24-hour dermal administration of the test item, Gelb Sulfato did not cause mortality and toxic dermal alterations in male and female CRL:(WI)BR rats.
The acute dermal LD50 value of the test item Gelb Sulfato was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.
Gelb Sulfato does not meet the criteria for classification according to EU labelling regulations for classification and labelling of dangerous substances.
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